Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Respiratory Research
Published in: Respiratory Research 1/2022

Open Access 01-12-2022 | Bronchiectasis | Research

Effects of long-term tobramycin inhalation solution (TIS) once daily on exacerbation rate in patients with non-cystic fibrosis bronchiectasis

Authors: Lotte C. Terpstra, Josje Altenburg, Inez Bronsveld, Martijn D. de Kruif, Yvonne Berk, Dominic Snijders, Wouter Rozemeijer, Harry G. M. Heijerman, Wim G. Boersma

Published in: Respiratory Research | Issue 1/2022

Login to get access

Abstract

Background

Use of long-term tobramycin inhalation solution (TIS) has been shown beneficial in cystic fibrosis (CF) and earlier findings also suggest a benefit in non-CF bronchiectasis. We investigated the efficacy and safety of maintenance TIS once daily (OD) in frequent exacerbating bronchiectasis patients chronically infected by different pathogens sensitive for tobramycin.

Objective

The primary outcome was the frequency of exacerbations during the 12-month study period. Secondary outcomes were time to first exacerbation, change in lung function and quality of life (QoL), bacterial analysis and safety.

Materials/patients

In this multicenter RCT patients aged ≥ 18-year-old were included with confirmed bronchiectasis and ≥ 2 exacerbations in the preceding year. Patients were assigned (1:1) to receive TIS or placebo OD for 1-year.

Results

58 patients were included of which 52 were analyzed in the mITT analysis. TIS reduced exacerbation frequency with a RR of 0.74 (95% CI 0.49–1.14) (p = 0.15). Within the TIS population a decrease in number of exacerbations was found (2; p = 0.00), which was also seen in the placebo-treated patients (1.5; p = 0.00). In the TIS-treated patients the QoL improved (LRTI-VAS p = 0.02 Leicester Cough p = 0.02) without additional safety concerns. No differences were found for the other secondary outcomes.

Conclusion

Long-term TIS OD is a safe treatment modality and showed a non-significant reduced exacerbation frequency of 0.74 as compared to placebo in bronchiectasis patients chronically infected by tobramycin sensitive pathogens. TIS OD may be a potential therapeutic strategy in selected patients with bronchiectasis suffering from a high burden of disease.
Trail registration number: The BATTLE study was registered at Clinical trials.gov number: NCT02657473. Date: 13 august 2016.
Appendix
Available only for authorised users
Literature
1.
Chalmers JD, Goeminne P, Aliberti S, et al. The bronchiectasis severity index. An international derivation and validation study. Am J Respir Crit Care Med. 2014;189(5):576–85.CrossRefPubMedPubMedCentral
2.
Terpstra LC, Biesenbeek S, Altenburg J, Boersma WG. Aetiology and disease severity are among the determinants of quality of life in bronchiectasis. Clin Respir J. 2019;13(8):521–9.CrossRefPubMed
3.
Chalmers JD, Boersma W, Lonergan M, et al. Long-term macrolide antibiotics for the treatment of bronchiectasis in adults: an individual participant data meta-analysis. Lancet Respir Med. 2019;7(10):845–54.CrossRefPubMed
4.
Martínez-García MA, Soler-Cataluña JJ, Perpiñá-Tordera M, Román-Sánchez P, Soriano J. Factors associated with lung function decline in adult patients with stable non-cystic fibrosis bronchiectasis. Chest. 2007;132(5):1565–72.CrossRefPubMed
5.
McDonnell MJ, Aliberti S, Goeminne PC, et al. Comorbidities and the risk of mortality in patients with bronchiectasis: an international multicentre cohort study. Lancet Respir Med. 2016;4(12):969–79.CrossRefPubMedPubMedCentral
6.
7.
Altenburg J, de Graaff CS, Stienstra Y, et al. Effect of azithromycin maintenance treatment on infectious exacerbations among patients with non–cystic fibrosis bronchiectasis: the BAT randomized controlled trial. JAMA. 2013;309(12):1251–9.CrossRefPubMed
8.
Laska IF, Crichton ML, Shoemark A, Chalmers JD. The efficacy and safety of inhaled antibiotics for the treatment of bronchiectasis in adults: a systematic review and meta-analysis. Lancet Respir Med. 2019;7(10):855–69.CrossRefPubMed
9.
10.
11.
Chalmers JD, Smith MP, McHugh BJ, Doherty C, Govan JR, Hill AT. Short- and long-term antibiotic treatment reduces airway and systemic inflammation in non-cystic fibrosis bronchiectasis. Am J Respir Crit Care Med. 2012;186(7):657–65.CrossRefPubMed
12.
Rayner CFJ, Tillotson G, Cole PJ, Wilson R. Efficacy and safety of long-term ciprofloxacin in the management of severe bronchiectasis. J Antimicrob Chemother. 1994;34(1):149–56.CrossRefPubMed
13.
14.
15.
16.
Castellani C, Duff AJA, Bell SC, et al. ECFS best practice guidelines: the 2018 revision. J Cyst Fibros. 2018;17(2):153–78.CrossRefPubMed
17.
Wiesemann HG, Steinkamp G, Ratjen F, et al. Placebo-controlled, double-blind, randomized study of aerosolized tobramycin for early treatment of Pseudomonas aeruginosa colonization in cystic fibrosis. Pediatr Pulmonol. 1998;25(2):88–92.CrossRefPubMed
18.
19.
20.
Scheinberg P, Shore E, group PT 008 study. A pilot study of the safety and efficacy of tobramycin solution for inhalation in patients with severe bronchiectasis. Chest. 2005;127(4):1420–6.PubMed
21.
Barker AF, Couch L, Fiel SB, et al. Tobramycin solution for inhalation reduces sputum Pseudomonas aeruginosa density in bronchiectasis. Am J Respir Crit Care Med. 2000;162(2):481–5.CrossRefPubMed
22.
23.
Orriols R, Roig J, Ferrer J. Inhaled antibiotic therapy in non-cysti fibrosis patients with bronchiectasis and chronic bronchial infection by Pseudomonas aeruginosa. Resp Med. 1999;93:476–80.CrossRef
24.
25.
26.
27.
28.
29.
30.
31.
32.
Ramsey BW. Intermittent administration of inhaled tobramycin in patients with cystic fibrosis. Cystic Fibrosis Inhaled Tobramycin Study Group. N Engl J Med. 1999;340(1):23–30.CrossRefPubMed
33.
Ramsey BW. Efficacy of aerosolized tobramycin in patients with cystic fibrosis. N Engl J Med. 1993;328(24):1740–6.CrossRefPubMed
34.
Bates RD, Nahata MC, Jones JW, et al. Pharmacokinetics and safety of tobramycin after once-daily administration in patients with cystic fibrosis. Chest. 1997;112(5):1208–13.CrossRefPubMed
35.
van Koningsbruggen-Rietschel S. Pharmacokinetics and safety of an 8 week continuous treatment with once-daily versus twice-daily inhalation of tobramycin in cystic fibrosis patients. J Antimicrob Chemother. 2016;71(3):711–7.CrossRefPubMed
36.
Maglio D, Nightingale CH, Nicolau DP. Extended interval aminoglycoside dosing: from concept to clinic. Int J Antimicrob Agents. 2002;19(4):341–8.CrossRefPubMed
37.
38.
Scaglione F, Paraboni L. Influence of pharmacokinetics/pharmacodynamics of antibacterials in their dosing regimen selection. Expert Rev Anti Infect Ther. 2006;4(3):479–90.CrossRefPubMed
39.
40.
41.
Metadata
Title
Effects of long-term tobramycin inhalation solution (TIS) once daily on exacerbation rate in patients with non-cystic fibrosis bronchiectasis
Authors
Lotte C. Terpstra
Josje Altenburg
Inez Bronsveld
Martijn D. de Kruif
Yvonne Berk
Dominic Snijders
Wouter Rozemeijer
Harry G. M. Heijerman
Wim G. Boersma
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Respiratory Research / Issue 1/2022
Electronic ISSN: 1465-993X
DOI
https://doi.org/10.1186/s12931-022-02243-y

Other articles of this Issue 1/2022

Respiratory Research 1/2022 Go to the issue

Research

Local nebulization of 1α,25(OH)2D3 attenuates LPS-induced acute lung inflammation

Research

Assessing the impact of air pollutants on clinical visits for childhood allergic respiratory disease induced by house dust mite in Shanghai, China

Research

Iron in airway macrophages and infective exacerbations of chronic obstructive pulmonary disease

Research

The role of retinoid-related orphan receptor-α in cigarette smoke-induced autophagic response

Study Protocol

The Establishment of China Bronchiectasis Registry and Research Collaboration (BE-China): Protocol of a prospective multicenter observational study

Research

Th1 cytokines synergize to change gene expression and promote corticosteroid insensitivity in pediatric airway smooth muscle
Live Webinar | 27-06-2024 | 18:00 (CEST)

Keynote webinar | Spotlight on medication adherence

Reserve your place

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

WHO estimates that half of all patients worldwide are non-adherent to their prescribed medication. The consequences of poor adherence can be catastrophic, on both the individual and population level.

Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.

Prof. Kevin Dolgin
Prof. Florian Limbourg
Prof. Anoop Chauhan
Developed by: Springer Medicine
Obesity Clinical Trial Summary

At a glance: The STEP trials

Read more

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine
Image Credits